Pharma Quality Engineer Consultant: Validation & Compliance

Krieger Scientific; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Krieger Scientific is seeking an experienced Quality Engineer Consultant to support a regulated pharmaceutical manufacturing operation in South Jersey. This hands-on role requires independent work within an active manufacturing environment, partnering with Quality, Manufacturing, Engineering, R&D, Supply Chain, and other technical teams.

The consultant will cover process validation, equipment qualification, CAPAs, change controls, risk assessments, technical documentation, and manufacturing

Qualifications

• Hands-on quality engineering in regulated pharma/bio/pharma environments.
• Experience authoring and executing validation protocols and reports.
• Strong CAPAs, deviations, change controls, and risk assessment expertise.
• Familiarity with FDA regulations; 21 CFR Parts 210/211; ISO 13485 a plus.
• Ability to translate regulatory requirements into practical docs.
• Excellent technical writing and communication skills.

Responsibilities

• Develop and execute validation strategies per regulatory requirements.
• Author, review, and approve equipment qualification and process validation protocols and reports.
• Lead root cause investigations and CAPA activities.
• Support change controls, risk assessments, and regulatory audits.
• Collaborate with Manufacturing, Engineering, and Quality teams to resolve issues.

Skills

Quality Engineering

GxP knowledge

Process validation

Equipment qualification

Root cause investigation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Krieger Scientific is seeking an experienced Quality Engineer Consultant to support a regulated pharmaceutical manufacturing operation in South Jersey. This hands-on role requires independent work within an active manufacturing environment, partnering with Quality, Manufacturing, Engineering, R&D, Supply Chain, and other technical teams.

The consultant will cover process validation, equipment qualification, CAPAs, change controls, risk assessments, technical documentation, and manufacturing